Trial Outcomes & Findings for Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- High Risk Early Breast Cancer (NCT NCT03078751)
NCT ID: NCT03078751
Last Updated: 2021-10-11
Results Overview
These are the number of participants who had adverse events or serious adverse events regardless of whether is was suspected to be drug-related or not
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
Up to 26 months
Results posted on
2021-10-11
Participant Flow
The study was closed early for recruitment and amended into an open-label, multi-centre, Phase II, conducted in the US only. A total of 54 patients were enrolled and randomized (26 in the ribociclib + ET arm and 28 in placebo + ET arm) at the time of recruitment closure. All randomized patients were unblinded. Patients randomized to placebo were permanently discontinued from the study and patients on ribociclib + ET were offered the option to continue treatment.
Approximately 2000 patients were planned to be enrolled in the study.
Participant milestones
| Measure |
Ribociclib + Adjuvant Endocrine Therapy (ET)
Patients in this arm took Ribociclib in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen (Tamoxifen no longer permitted after protocol amendment 2)
|
Placebo + Adjuvant Endocrine Therapy (ET)
Patients in this arm took Placebo in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
28
|
|
Overall Study
Untreated Participants
|
0
|
4
|
|
Overall Study
Safety Set
|
26
|
24
|
|
Overall Study
COMPLETED
|
13
|
0
|
|
Overall Study
NOT COMPLETED
|
13
|
28
|
Reasons for withdrawal
| Measure |
Ribociclib + Adjuvant Endocrine Therapy (ET)
Patients in this arm took Ribociclib in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen (Tamoxifen no longer permitted after protocol amendment 2)
|
Placebo + Adjuvant Endocrine Therapy (ET)
Patients in this arm took Placebo in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Terminated by Sponsor = early terminated recruitment
|
0
|
23
|
|
Overall Study
Subject/guardian decision
|
8
|
1
|
|
Overall Study
Untreated
|
0
|
4
|
Baseline Characteristics
Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- High Risk Early Breast Cancer
Baseline characteristics by cohort
| Measure |
Ribociclib + Adjuvant Endocrine Therapy (ET)
n=26 Participants
Patients in this arm took Ribociclib in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen (Tamoxifen no longer permitted after protocol amendment 2)
|
Placebo + Adjuvant Endocrine Therapy (ET)
n=28 Participants
Patients in this arm took Placebo in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.7 Years
STANDARD_DEVIATION 11.23 • n=5 Participants
|
54.7 Years
STANDARD_DEVIATION 9.04 • n=7 Participants
|
55.7 Years
STANDARD_DEVIATION 10.11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 26 monthsPopulation: Safety set includes all patients who received at least one dose of any component of study treatment
These are the number of participants who had adverse events or serious adverse events regardless of whether is was suspected to be drug-related or not
Outcome measures
| Measure |
Ribociclib + Adjuvant Endocrine Therapy (ET)
n=26 Participants
Patients in this arm took Ribociclib in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen (Tamoxifen no longer permitted after protocol amendment 2)
|
Placebo + Adjuvant Endocrine Therapy (ET)
n=24 Participants
Patients in this arm took Placebo in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen
|
|---|---|---|
|
Number of Participants With Adverse Events and Serious Adverse Events
Adverse Events
|
25 Participants
|
21 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events
Serious Adverse Events
|
4 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to 26 monthsPopulation: Safety set includes all patients who received at least one dose of any component of study treatment
These are the percentage of participants that had adverse events or serious adverse events regardless of whether is was suspected to be drug-related or not
Outcome measures
| Measure |
Ribociclib + Adjuvant Endocrine Therapy (ET)
n=26 Participants
Patients in this arm took Ribociclib in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen (Tamoxifen no longer permitted after protocol amendment 2)
|
Placebo + Adjuvant Endocrine Therapy (ET)
n=24 Participants
Patients in this arm took Placebo in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen
|
|---|---|---|
|
Percentage of Participants With Adverse Events and Serious Adverse Events
Adverse Events
|
96.2 Percentage of participants
|
87.5 Percentage of participants
|
|
Percentage of Participants With Adverse Events and Serious Adverse Events
Serious Adverse Events
|
15.4 Percentage of participants
|
8.3 Percentage of participants
|
Adverse Events
Ribociclib + Adjuvant Endocrine Therapy (ET)
Serious events: 4 serious events
Other events: 25 other events
Deaths: 0 deaths
Placebo + Adjuvant Endocrine Therapy (ET)
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ribociclib + Adjuvant Endocrine Therapy (ET)
n=26 participants at risk
Patients in this arm took Ribociclib in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen (Tamoxifen no longer permitted after protocol amendment 2)
|
Placebo + Adjuvant Endocrine Therapy (ET)
n=24 participants at risk
Patients in this arm took Placebo in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen
|
|---|---|---|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
3.8%
1/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
3.8%
1/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Breast cellulitis
|
3.8%
1/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Cellulitis
|
3.8%
1/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
4.2%
1/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
3.8%
1/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Nervous system disorders
Seizure
|
0.00%
0/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
4.2%
1/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.8%
1/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
Other adverse events
| Measure |
Ribociclib + Adjuvant Endocrine Therapy (ET)
n=26 participants at risk
Patients in this arm took Ribociclib in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen (Tamoxifen no longer permitted after protocol amendment 2)
|
Placebo + Adjuvant Endocrine Therapy (ET)
n=24 participants at risk
Patients in this arm took Placebo in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen
|
|---|---|---|
|
General disorders
Chest pain
|
7.7%
2/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
23.1%
6/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
4.2%
1/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.7%
2/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
53.8%
14/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.5%
3/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Cardiac disorders
Palpitations
|
7.7%
2/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Eye disorders
Vision blurred
|
7.7%
2/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
19.2%
5/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.5%
3/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Constipation
|
23.1%
6/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
23.1%
6/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
4.2%
1/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
15.4%
4/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Nausea
|
46.2%
12/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
25.0%
6/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
11.5%
3/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Gastrointestinal disorders
Vomiting
|
15.4%
4/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
12.5%
3/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
General disorders
Axillary pain
|
3.8%
1/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
8.3%
2/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
General disorders
Fatigue
|
46.2%
12/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
4.2%
1/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
General disorders
Influenza like illness
|
7.7%
2/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
General disorders
Oedema peripheral
|
11.5%
3/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
4.2%
1/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
General disorders
Pain
|
11.5%
3/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
General disorders
Pyrexia
|
15.4%
4/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
4.2%
1/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Herpes zoster
|
7.7%
2/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Influenza
|
7.7%
2/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
8.3%
2/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Nasopharyngitis
|
19.2%
5/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Pneumonia
|
7.7%
2/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Sinusitis
|
7.7%
2/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
8.3%
2/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
19.2%
5/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
4.2%
1/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Infections and infestations
Urinary tract infection
|
11.5%
3/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
7.7%
2/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
7.7%
2/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
4.2%
1/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
7.7%
2/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Investigations
Alanine aminotransferase increased
|
19.2%
5/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
11.5%
3/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Investigations
Blood calcium decreased
|
7.7%
2/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Investigations
Blood cholesterol increased
|
7.7%
2/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Investigations
Blood creatinine increased
|
15.4%
4/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Investigations
Lymphocyte count decreased
|
15.4%
4/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Investigations
Neutrophil count decreased
|
26.9%
7/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Investigations
Weight increased
|
7.7%
2/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Investigations
White blood cell count decreased
|
38.5%
10/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.7%
2/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.7%
2/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
23.1%
6/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
29.2%
7/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.4%
4/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
4.2%
1/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.7%
2/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.7%
2/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
4.2%
1/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
15.4%
4/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
4.2%
1/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
11.5%
3/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
8.3%
2/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
2/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
16.7%
4/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.7%
2/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.5%
3/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
4.2%
1/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Nervous system disorders
Dizziness
|
15.4%
4/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
8.3%
2/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Nervous system disorders
Dysgeusia
|
7.7%
2/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Nervous system disorders
Headache
|
19.2%
5/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
8.3%
2/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
7.7%
2/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Psychiatric disorders
Confusional state
|
7.7%
2/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
8.3%
2/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
7.7%
2/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Reproductive system and breast disorders
Breast pain
|
7.7%
2/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
4.2%
1/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
26.9%
7/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
8.3%
2/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.7%
2/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
4.2%
1/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
15.4%
4/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
4.2%
1/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.7%
2/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
7.7%
2/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
7.7%
2/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
7.7%
2/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
7.7%
2/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
26.9%
7/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
4.2%
1/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
2/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
4.2%
1/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Vascular disorders
Hot flush
|
11.5%
3/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
12.5%
3/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
|
Vascular disorders
Lymphoedema
|
11.5%
3/26 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
0.00%
0/24 • Time Frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of approx. 26 months
Any sign or symptom that occurs during the study treatment plus 28 days post treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigators are NOT employed by the organization sponsoring the study. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial.
- Publication restrictions are in place
Restriction type: OTHER